The REMEDEE trial: 5-Year results on a novel combined sirolimus-eluting and endothelial progenitor cells capturing stent

Catheter Cardiovasc Interv. 2020 May 1;95(6):1076-1084. doi: 10.1002/ccd.28483. Epub 2019 Sep 5.

Abstract

Objectives: To evaluate the long-term safety and efficacy of the novel combined sirolimus-eluting endothelial progenitor cell capture Combo stent (OrbusNeich, Fort Lauderdale, FL) at 5 years in the REMEDEE (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coated bio-Engineered stEnt) trial.

Background: Drug-eluting stents have limited restenosis and reintervention but are complicated by late and very late thrombosis and accelerated neoatherosclerosis. Alternative or adjunctive technologies are needed to address these limitations.

Methods: A total of 183 patients with de novo lesions in native coronary arteries were randomized 2:1 to Combo (n = 124) or Taxus Liberté (n = 59). Primary endpoint was 9 month angiographic in-stent late lumen loss and the secondary endpoint was the occurrence of major adverse events (MACE) through 5-year follow-up.

Results: Compared with Taxus, after 5 years the Combo stent was associated with similar rates of MACE (18.3% vs. 16.9%, p = .89), cardiac death (0.8% vs. 5.1%, p = .07), myocardial infarction (4.1% vs. 3.4%, p = .81), target lesion (9.4% vs. 10.2%, p = .78), and target vessel revascularization (14.4% vs. 11.9%, p = .73). No cases of definite stent thrombosis were reported in the Combo group. The follow-up rate at 5 years was 97.7%.

Conclusion: At 5-year follow-up, the Combo stent remained clinically safe and effective with an overall low rate of MACE comparable to Taxus.

Keywords: drug-eluting stents; percutaneous coronary intervention; progenitor endothelial cells; sirolimus.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Cardiovascular Agents / administration & dosage*
  • Cardiovascular Agents / adverse effects
  • Coronary Artery Disease / diagnostic imaging
  • Coronary Artery Disease / mortality
  • Coronary Artery Disease / pathology
  • Coronary Artery Disease / therapy*
  • Coronary Restenosis / etiology
  • Coronary Thrombosis / etiology
  • Drug-Eluting Stents*
  • Endothelial Progenitor Cells / pathology*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Percutaneous Coronary Intervention / adverse effects
  • Percutaneous Coronary Intervention / instrumentation*
  • Percutaneous Coronary Intervention / mortality
  • Prospective Studies
  • Risk Factors
  • Sirolimus / administration & dosage*
  • Sirolimus / adverse effects
  • Time Factors
  • Treatment Outcome

Substances

  • Cardiovascular Agents
  • Sirolimus